Efficacy of a topical formulation of Henna (Lawsonia inermis) on the itch and wound healing in patients with epidermolysis bullosa: A pilot single-arm clinical trial
Keywords:
epidermolysis bullosa, Lawsonia plant, wound healing, pruritus, complementary therapiesAbstract
Introduction: Epidermolysis bullosa (EB) is a rare inherited genetic skin disorder with severe skin itching and recurrent blisters and erosion. There is no effective and specific therapy for all types of EB.
Objective: The aim of this study was to evaluate a topical formulation of henna (Lawsonia inermis L.) in the management of wounds and the itching sensation in patients with EB.
Methods: This is a pilot single-arm clinical trial. Nine patients with recessive dystrophic EB (RDEB), with the age range of 5 to 32 years old were enrolled in the study. The patients were instructed to apply the topical 1% henna ointment once daily on two erosions and on also two sites with moderate to a severe itching sensation. The total duration of the intervention was four weeks with weekly follow-up visits. Patient global impression of improvement (PGI-I), visual analog scale (VAS), and clinical global impression of improvement (CGI-I) were used for assessing the wound healing process and itching discomfort.
Results: There was a significant improvement in the skin symptoms of epidermolysis bullosa including skin redness, itching, burning, and local warmness (p-value<0.05). Local pain decreased during the study period, but this was not statistically significant (p-value<0. 0.19). One patient reported moderate xerosis of skin after continuous usage.
Conclusion: It seems that the topical formulation of henna may be effective in the management of itching, burning, stringing, and cutaneous warmness sensation in patients with EB. Further controlled studies with larger sample sizes are recommended to better evaluate this formulation.
References
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2. Fine JD. Epidemiology of Inherited Epidermolysis Bullosa Based on Incidence and Prevalence Estimates From the National Epidermolysis Bullosa Registry. JAMA dermatology. Nov 1 2016;152(11):1231-1238. doi:10.1001/jamadermatol.2016.2473
3. Fine JD, Bruckner-Tuderman L, Eady RA, et al. Inherited epidermolysis bullosa: updated recommendations on diagnosis and classification. J Am Acad Dermatol. 2014;70(6):1103-1126.
4. Fine JD. Inherited epidermolysis bullosa. Orphanet J Rare Dis. 2010;5(1):12.
5. Rizzo C, Anandasabapathy N, Walters RF, et al. Pretibial epidermolysis bullosa. Dermatology online journal. Oct 15 2008;14(10):26.
6. El Hachem M, Zambruno G, Bourdon-Lanoy E, et al. Multicentre consensus recommendations for skin care in inherited epidermolysis bullosa. Orphanet J Rare Dis. May 20 2014;9:76. doi:10.1186/1750-1172-9-76
7. Aghili Khorasani MH. Makhzan al-Advieh. Tehran: Tehran University of Medical Sciences. 2009:341.
8. Arzani MA. Teb-e-Akbari. Qom, Iran: Jalaledin Publication. 2008;
9. Rafiei Z, Mazaheri M, Eghbali-Babadi M, Yazdannik A. The Effect of Henna (Lawsonia Inermis) on Preventing the Development of Pressure Ulcer Grade One in Intensive Care Unit Patients. International journal of preventive medicine. 2019;10:26. doi:10.4103/ijpvm.IJPVM_286_17
10. Keshavarz A, Zeinaloo AA, Mahram M, Mohammadi N, Sadeghpour O, Maleki MR. Efficacy of Traditional Medicine Product Henna and Hydrocortisone on Diaper Dermatitis in Infants. Iranian Red Crescent medical journal. May 2016;18(5):e24809. doi:10.5812/ircmj.24809
11. Rekik DM, Ben Khedir S, Daoud A, Ksouda Moalla K, Rebai T, Sahnoun Z. Wound Healing Effect of Lawsonia inermis. Skin pharmacology and physiology. 2019;32(6):295-306. doi:10.1159/000501730
12. Niazi M, Mehrabani M, Namazi MR, et al. Efficacy of a topical formulation of henna (Lawsonia inermis L.) in contact dermatitis in patients using prosthesis: A double-blind randomized placebo-controlled clinical trial. Complement Ther Med. 2020:102316.
13. Jridi M, Sellimi S, Lassoued KB, et al. Wound healing activity of cuttlefish gelatin gels and films enriched by henna (Lawsonia inermis) extract. Colloids Surf A Physicochem Eng Asp. 2017;512:71-79.
14. Negahdari S, Galehdari H, Kesmati M, Rezaie A, Shariati G. Wound healing activity of extracts and formulations of aloe vera, henna, adiantum capillus-veneris, and myrrh on mouse dermal fibroblast cells. International journal of preventive medicine. 2017;8
15. Kulkarni S, Kale V, Velankar K. To study the Photodynamic antimicrobial activity of Henna extract and preparation of topical Gel formulation. The Journal of Phytopharmacology. 2018;7(3):242-252.
16. Nawasrah A, AlNimr A, Ali A. Antifungal effect of Henna against Candida albicans adhered to acrylic resin as a possible method for prevention of denture stomatitis. Int J Environ Res Public Health. 2016;13(5):520.
17. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama. Nov 27 2013;310(20):2191-4. doi:10.1001/jama.2013.281053
18. World Health Organization. Quality control methods for herbal materials: updated edition of Quality control methods for medicinal plant materials, 1998. WHO; 2011.
19. Akhtar N, Khan AB, Muhammad S, et al. Formulation and characterization of a cream containing terminalia chebula extract. Forsch Komplementmed. 2012;19(1):20-5. doi:10.1159/000335823
20. Moldovan M, Lahmar A, Bogdan C, Părăuan S, Tomuţă I, Crişan M. Formulation and evaluation of a water-in-oil cream containing herbal active ingredients and ferulic acid. Clujul Med. 2017;90(2):212-219. doi:10.15386/cjmed-668
21. Shriwas S, Choukse R, Dwivedi S. Formulation and evaluation of herbal cream containing hydroalcoholic extract of Ipomea cairica Linn. for the treatment of gynecological disorders. Acta Scientific Medical Sciences. 2019;3(8):192-196.
22. Garg A, Aggarwal D, Garg S, Singla AK. Spreading of semisolid formulations: an update. Pharmaceutical technology. 2002;26(9):84-105.
23. Rover MR, Brown RC. Quantification of total phenols in bio-oil using the Folin–Ciocalteu method. J Anal Appl Pyrolysis. 2013;104:366-371.
24. Bruckner-Tuderman L. Dystrophic epidermolysis bullosa: pathogenesis and clinical features. Dermatol Clin. 2010;28(1):107-114.
25. Pagliarello C, Tabolli S. Factors affecting quality of life in epidermolysis bullosa. Expert Rev Pharmacoecon Outcomes Res. 2010;10(3):329-338.
26. Shayegan LH, Levin LE, Galligan ER, et al. Skin cleansing and topical product use in patients with epidermolysis bullosa: Results from a multicenter database. Pediatr Dermatol. 2020;37(2):326-332.
27. Al Saif F. Henna beyond skin arts: Literatures review. Journal of Pakistan Association of Dermatology. 2016;26(1):58-65.
28. Jorjani SE. Zakhireh Kharazmshahi. Ehyae teb-e-tabiei; 2012.
29. McKay M. Clinical Methods: The History, Physical, and Laboratory Examinations. In: Walker HK, Hall WD, Hurst JW, eds. Office Techniques for Dermatologic Diagnosis. 3rd ed. Butterworths; 1990:chap 109.
30. Ansari M, Dehsara F, Mosalaei A, Omidvari S, Ahmadloo N, Mohammadianpanah M. Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial. Iran J Med Sci. 2013;38(4):293.
31. Yucel I, Guzin G. Topical henna for capecitabine induced hand–foot syndrome. Investigational new drugs. 2008;26(2):189-192.
32. Shiravi AH, Alebooyeh M, Hojati V, Akbari H. The effect of extract of henna leaves (Lawsonia inermis) on skin wound healing in Wistar rats. Journal of Animal Biology. 2011;3(4):45-51.
33. Daemi A, Farahpour MR, Oryan A, Karimzadeh S, Tajer E. Topical administration of hydroethanolic extract of Lawsonia inermis (henna) accelerates excisional wound healing process by reducing tissue inflammation and amplifying glucose uptake. Kaohsiung J Med Sci. 2019;35(1):24-32.
34. Parvizi MM, Handjani F, Moein M, et al. Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. PLoS Negl Trop Dis. 2017;11(10):e0005957.
35. Jowkar F, Godarzi H, Parvizi MM. Can we consider silymarin as a treatment option for vitiligo? A double-blind controlled randomized clinical trial of phototherapy plus oral Silybum marianum product versus phototherapy alone. J Dermatolog Treat. 2019:1-5.
36. Qarshi IN. Al-Mujaz fi al-Tibb. Islamic Heritage Revival Committee, Supreme Council for Islamic Affairs, Ministry of Endowments; 2004.
37. Nesa L, Munira S, Mollika S, Islam M. Evaluation of analgesic, anti-inflammatory and CNS depressant activities of methanolic extract of Lawsonia inermis barks in mice. Avicenna J Phytomed. 2014;4(4):287.
38. Imam H, Mahbub NU, Khan MF, Hana HK, Sarker MMR. Alpha Amylase Enzyme Inhibitory and Anti-inflammatory Effect of Lawsonia inermis. Pak J Biol Sci. 2013;16(23):1796-1800.
39. Nawaf AM, Joshi A, Nour‐Eldin O. Acute allergic contact dermatitis due to para‐phenylenediamine after temporary henna painting. J Dermatol. 2003;30(11):797-800.
40. del Boz J, Martin T, Samaniego E, Vera A, MorON D, Crespo V. Temporary localized hypertrichosis after henna pseudotattoo. Pediatr Dermatol. 2008;25(2):274-275.
41. Matulich J, Sullivan J. A temporary henna tattoo causing hair and clothing dye allergy. Contact Dermatitis. 2005;53(1):33-36.
42. Sidwell RU, Francis ND, Basarab T, Morar N. Vesicular erythema multiforme‐like reaction to para‐phenylenediamine in a henna tattoo. Pediatr Dermatol. 2008;25(2):201-204.
43. Lee SWH, Lai NM, Chaiyakunapruk N, Chong DWK. Adverse effects of herbal or dietary supplements in G6PD deficiency: a systematic review. Br J Clin Pharmacol. 2017;83(1):172-179.
44. Poursadra E, Anvari-Tafti M, Dehghani A, Eghbali-Babadi M, Rafiei Z. Comparing the Effect of Henna Oil and Olive Oil on Pressure Ulcer Grade One in Intensive Care Units Patients. Advanced biomedical research. 2019;8:68. doi:10.4103/abr.abr_207_19
45. Vahabi S, Hakemi-Vala M, Gholami S. In vitro Antibacterial Effect of Hydroalcoholic Extract of Lawsonia inermis, Malva sylvestris, and Boswellia serrata on Aggregatibacter actinomycetemcomitans. Advanced biomedical research. 2019;8:22. doi:10.4103/abr.abr_205_18
46. Zheng Y, Hu Y, Liu K, Lu Y, Hu Y, Zhou X. [Therapeutic effect of Impatiens balsamina, Lawsonia inermis L. and Henna on androgenetic alopecia in mice]. Nan fang yi ke da xue xue bao = Journal of Southern Medical University. Nov 30 2019;39(11):1376-1380. doi:10.12122/j.issn.1673-4254.2019.11.17
2. Fine JD. Epidemiology of Inherited Epidermolysis Bullosa Based on Incidence and Prevalence Estimates From the National Epidermolysis Bullosa Registry. JAMA dermatology. Nov 1 2016;152(11):1231-1238. doi:10.1001/jamadermatol.2016.2473
3. Fine JD, Bruckner-Tuderman L, Eady RA, et al. Inherited epidermolysis bullosa: updated recommendations on diagnosis and classification. J Am Acad Dermatol. 2014;70(6):1103-1126.
4. Fine JD. Inherited epidermolysis bullosa. Orphanet J Rare Dis. 2010;5(1):12.
5. Rizzo C, Anandasabapathy N, Walters RF, et al. Pretibial epidermolysis bullosa. Dermatology online journal. Oct 15 2008;14(10):26.
6. El Hachem M, Zambruno G, Bourdon-Lanoy E, et al. Multicentre consensus recommendations for skin care in inherited epidermolysis bullosa. Orphanet J Rare Dis. May 20 2014;9:76. doi:10.1186/1750-1172-9-76
7. Aghili Khorasani MH. Makhzan al-Advieh. Tehran: Tehran University of Medical Sciences. 2009:341.
8. Arzani MA. Teb-e-Akbari. Qom, Iran: Jalaledin Publication. 2008;
9. Rafiei Z, Mazaheri M, Eghbali-Babadi M, Yazdannik A. The Effect of Henna (Lawsonia Inermis) on Preventing the Development of Pressure Ulcer Grade One in Intensive Care Unit Patients. International journal of preventive medicine. 2019;10:26. doi:10.4103/ijpvm.IJPVM_286_17
10. Keshavarz A, Zeinaloo AA, Mahram M, Mohammadi N, Sadeghpour O, Maleki MR. Efficacy of Traditional Medicine Product Henna and Hydrocortisone on Diaper Dermatitis in Infants. Iranian Red Crescent medical journal. May 2016;18(5):e24809. doi:10.5812/ircmj.24809
11. Rekik DM, Ben Khedir S, Daoud A, Ksouda Moalla K, Rebai T, Sahnoun Z. Wound Healing Effect of Lawsonia inermis. Skin pharmacology and physiology. 2019;32(6):295-306. doi:10.1159/000501730
12. Niazi M, Mehrabani M, Namazi MR, et al. Efficacy of a topical formulation of henna (Lawsonia inermis L.) in contact dermatitis in patients using prosthesis: A double-blind randomized placebo-controlled clinical trial. Complement Ther Med. 2020:102316.
13. Jridi M, Sellimi S, Lassoued KB, et al. Wound healing activity of cuttlefish gelatin gels and films enriched by henna (Lawsonia inermis) extract. Colloids Surf A Physicochem Eng Asp. 2017;512:71-79.
14. Negahdari S, Galehdari H, Kesmati M, Rezaie A, Shariati G. Wound healing activity of extracts and formulations of aloe vera, henna, adiantum capillus-veneris, and myrrh on mouse dermal fibroblast cells. International journal of preventive medicine. 2017;8
15. Kulkarni S, Kale V, Velankar K. To study the Photodynamic antimicrobial activity of Henna extract and preparation of topical Gel formulation. The Journal of Phytopharmacology. 2018;7(3):242-252.
16. Nawasrah A, AlNimr A, Ali A. Antifungal effect of Henna against Candida albicans adhered to acrylic resin as a possible method for prevention of denture stomatitis. Int J Environ Res Public Health. 2016;13(5):520.
17. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama. Nov 27 2013;310(20):2191-4. doi:10.1001/jama.2013.281053
18. World Health Organization. Quality control methods for herbal materials: updated edition of Quality control methods for medicinal plant materials, 1998. WHO; 2011.
19. Akhtar N, Khan AB, Muhammad S, et al. Formulation and characterization of a cream containing terminalia chebula extract. Forsch Komplementmed. 2012;19(1):20-5. doi:10.1159/000335823
20. Moldovan M, Lahmar A, Bogdan C, Părăuan S, Tomuţă I, Crişan M. Formulation and evaluation of a water-in-oil cream containing herbal active ingredients and ferulic acid. Clujul Med. 2017;90(2):212-219. doi:10.15386/cjmed-668
21. Shriwas S, Choukse R, Dwivedi S. Formulation and evaluation of herbal cream containing hydroalcoholic extract of Ipomea cairica Linn. for the treatment of gynecological disorders. Acta Scientific Medical Sciences. 2019;3(8):192-196.
22. Garg A, Aggarwal D, Garg S, Singla AK. Spreading of semisolid formulations: an update. Pharmaceutical technology. 2002;26(9):84-105.
23. Rover MR, Brown RC. Quantification of total phenols in bio-oil using the Folin–Ciocalteu method. J Anal Appl Pyrolysis. 2013;104:366-371.
24. Bruckner-Tuderman L. Dystrophic epidermolysis bullosa: pathogenesis and clinical features. Dermatol Clin. 2010;28(1):107-114.
25. Pagliarello C, Tabolli S. Factors affecting quality of life in epidermolysis bullosa. Expert Rev Pharmacoecon Outcomes Res. 2010;10(3):329-338.
26. Shayegan LH, Levin LE, Galligan ER, et al. Skin cleansing and topical product use in patients with epidermolysis bullosa: Results from a multicenter database. Pediatr Dermatol. 2020;37(2):326-332.
27. Al Saif F. Henna beyond skin arts: Literatures review. Journal of Pakistan Association of Dermatology. 2016;26(1):58-65.
28. Jorjani SE. Zakhireh Kharazmshahi. Ehyae teb-e-tabiei; 2012.
29. McKay M. Clinical Methods: The History, Physical, and Laboratory Examinations. In: Walker HK, Hall WD, Hurst JW, eds. Office Techniques for Dermatologic Diagnosis. 3rd ed. Butterworths; 1990:chap 109.
30. Ansari M, Dehsara F, Mosalaei A, Omidvari S, Ahmadloo N, Mohammadianpanah M. Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial. Iran J Med Sci. 2013;38(4):293.
31. Yucel I, Guzin G. Topical henna for capecitabine induced hand–foot syndrome. Investigational new drugs. 2008;26(2):189-192.
32. Shiravi AH, Alebooyeh M, Hojati V, Akbari H. The effect of extract of henna leaves (Lawsonia inermis) on skin wound healing in Wistar rats. Journal of Animal Biology. 2011;3(4):45-51.
33. Daemi A, Farahpour MR, Oryan A, Karimzadeh S, Tajer E. Topical administration of hydroethanolic extract of Lawsonia inermis (henna) accelerates excisional wound healing process by reducing tissue inflammation and amplifying glucose uptake. Kaohsiung J Med Sci. 2019;35(1):24-32.
34. Parvizi MM, Handjani F, Moein M, et al. Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. PLoS Negl Trop Dis. 2017;11(10):e0005957.
35. Jowkar F, Godarzi H, Parvizi MM. Can we consider silymarin as a treatment option for vitiligo? A double-blind controlled randomized clinical trial of phototherapy plus oral Silybum marianum product versus phototherapy alone. J Dermatolog Treat. 2019:1-5.
36. Qarshi IN. Al-Mujaz fi al-Tibb. Islamic Heritage Revival Committee, Supreme Council for Islamic Affairs, Ministry of Endowments; 2004.
37. Nesa L, Munira S, Mollika S, Islam M. Evaluation of analgesic, anti-inflammatory and CNS depressant activities of methanolic extract of Lawsonia inermis barks in mice. Avicenna J Phytomed. 2014;4(4):287.
38. Imam H, Mahbub NU, Khan MF, Hana HK, Sarker MMR. Alpha Amylase Enzyme Inhibitory and Anti-inflammatory Effect of Lawsonia inermis. Pak J Biol Sci. 2013;16(23):1796-1800.
39. Nawaf AM, Joshi A, Nour‐Eldin O. Acute allergic contact dermatitis due to para‐phenylenediamine after temporary henna painting. J Dermatol. 2003;30(11):797-800.
40. del Boz J, Martin T, Samaniego E, Vera A, MorON D, Crespo V. Temporary localized hypertrichosis after henna pseudotattoo. Pediatr Dermatol. 2008;25(2):274-275.
41. Matulich J, Sullivan J. A temporary henna tattoo causing hair and clothing dye allergy. Contact Dermatitis. 2005;53(1):33-36.
42. Sidwell RU, Francis ND, Basarab T, Morar N. Vesicular erythema multiforme‐like reaction to para‐phenylenediamine in a henna tattoo. Pediatr Dermatol. 2008;25(2):201-204.
43. Lee SWH, Lai NM, Chaiyakunapruk N, Chong DWK. Adverse effects of herbal or dietary supplements in G6PD deficiency: a systematic review. Br J Clin Pharmacol. 2017;83(1):172-179.
44. Poursadra E, Anvari-Tafti M, Dehghani A, Eghbali-Babadi M, Rafiei Z. Comparing the Effect of Henna Oil and Olive Oil on Pressure Ulcer Grade One in Intensive Care Units Patients. Advanced biomedical research. 2019;8:68. doi:10.4103/abr.abr_207_19
45. Vahabi S, Hakemi-Vala M, Gholami S. In vitro Antibacterial Effect of Hydroalcoholic Extract of Lawsonia inermis, Malva sylvestris, and Boswellia serrata on Aggregatibacter actinomycetemcomitans. Advanced biomedical research. 2019;8:22. doi:10.4103/abr.abr_205_18
46. Zheng Y, Hu Y, Liu K, Lu Y, Hu Y, Zhou X. [Therapeutic effect of Impatiens balsamina, Lawsonia inermis L. and Henna on androgenetic alopecia in mice]. Nan fang yi ke da xue xue bao = Journal of Southern Medical University. Nov 30 2019;39(11):1376-1380. doi:10.12122/j.issn.1673-4254.2019.11.17
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2022-07-28
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1.
Efficacy of a topical formulation of Henna (Lawsonia inermis) on the itch and wound healing in patients with epidermolysis bullosa: A pilot single-arm clinical trial. Dermatol Pract Concept [Internet]. 2022 Jul. 28 [cited 2024 May 17];12(3):e2022115. Available from: https://dpcj.org/index.php/dpc/article/view/2020
